The Human Sperm Survival Assay (HSSA) as an Internal Quality Control for the IVF Consumables (REPROTOX 2)

NCT05100784 | Completed

• 1 other identifier: 2020-A01972-37
• Study Type: observational
• Target: 826
• Locations: 1 country
• Sites: 1

Brief Summary

The main embryotoxicity quality controls are the mouse embryo test (MEA = Mouse Embryo Assay) and the human sperm survival test (HSSA = Human Sperm Survival Assay). The HSSA test measures the survival (or mobility) of human sperm after exposure to the tested consumable for a predetermined period of time and compares it to that of unexposed sperm. It would appear that the HSSA is comparable in terms of sensitivity to the MEA test for the detection of toxicity.

Conditions

Human Sperm Survival Assay; Embryotoxicity; in Vitro Fertilization

Outcome Measures

Primary Outcomes (1)

• Presence of embryotoxicity

  Presence of embryotoxicity, defined by a mobility index relative to the control (SMI) \<0.85 observed on at least 2 of the three tests carried out on consumables from the same batch (isolated embryotoxicity).

  1 day

Study Arms (1)

Sperm with normal spermogramm and more than 10 millions spermatozoids

Normal spermogramm : concentration ≥15 million / ml or total count\> 39 million, progressive mobility ≥32% or total mobility ≥40%

Biological: HSSA test

Interventions

HSSA test BIOLOGICAL

Human Sperm Survival Assay testing performed on different batches of different types of IVF consumables. In practice, 3 consumables from the same batch will be tested with 3 different sperms to ensure the repeatability of the result / test.

Sperm with normal spermogramm and more than 10 millions spermatozoids

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male between 18 and 65 years-old with normal spermogram

You may qualify if:

• Male over 18 years-old
• Normal spermogram (concentration ≥15 million / ml or total count\> 39 million, progressive mobility ≥32% or total mobility ≥40%)
• Progressive mobility ≥70% after selection
• Total number of progressive motile spermatozoa recovered after TMS\> 10 million
• Patient affiliated or beneficiary of a social security scheme
• Patient having been informed and not opposing to this research.

You may not qualify if:

• Male over 65 years-old
• Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision

Sponsors & Collaborators

• European Clinical Trial Experts Network: collaborator
• Private hospital Parly II: collaborator
• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Private Hospital of Parly II-Le Chesnay

Le Chesnay, 78150, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: October 29, 2021
• Study Start: March 10, 2021
• Primary Completion: January 16, 2023
• Study Completion: January 16, 2023
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

FR (1)